Study of Antibiotic Utilization Measures and Control of ESBLs in China

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00488813
First received: June 18, 2007
Last updated: September 4, 2009
Last verified: September 2009
  Purpose

A single-center, prospective, comparative, antibiotic intervention study for patients admitted to MICU1 and MICU2


Condition Intervention Phase
ICU Patient
Drug: Third generation cephalosporins
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Association of Antibiotic Utilization Measures and Control of Extended-spectrum β-lactamases (ESBLs) in MICU1 and MICU2 at Buddhist Tzu Chi General Hospital.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • For both MICU1 and MICU2 (acquisition), all culture results will be collected and recorded, then analyzed to determine the ESBL acquisition rate and bacterial isolates (E. coli or K. pneumoniae).

Estimated Enrollment: 300
Study Start Date: July 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Detailed Description:
  1. To determine the value of using β-lactamases inhibitors in reducing the cases of ESBL producing E. coli or K. pneumoniae colonization and infection after 12 months.
  2. To compare the acquisition rates of ESBL producing E. coli or K. pneumoniae at MICU1 and MICU2 after 12 months
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted or transferred to the ICU/burn units.
  • Patients of either sex, 18 years of age or older.

Exclusion Criteria:

  • Patient with hypersensitivity to penicillins, cephalosporins, and beta-lactamase inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00488813

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Taiwan, medinfo@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00488813     History of Changes
Other Study ID Numbers: 101441
Study First Received: June 18, 2007
Last Updated: September 4, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Tzh-Chi ESBL study

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cephalosporins
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 20, 2014